US Biosimilar Approvals In 2021 Were Few But Included Many Firsts

By David Wallace

biosimilar industry

While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.

With biosimilars increasingly gaining traction in the US in recent years, 2021 saw the US biosimilars market take further steps forward with a number of firsts.

Dissect how even though there were so many firsts for US biosimilars in 2021, international inspection constraints related to the COVID-19 pandemic prevented the FDA from conducting certain necessary inspections, pushing back the potential approvals of multiple biosimilar candidates.


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